Analysis of Crushed and Whole Tablet Genvoya

NCT03717129 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: IRB00110315IN-US-292-4089
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Step-wise, two sequential, single-dose, bioequivalence study in 12 healthy volunteers to determine whether crushed Genvoya tablet is bioequivalent to whole Genvoya tablet. The first study sequence will involve a directly observed single dose of the fixed dose formulation of whole Genvoya tablet, with semi-intensive pharmacokinetic serum sampling at time points following the dose. After a washout period of seven days, subjects will then receive a directly observed single dose of a crushed tablet of Genvoya with subsequent semi-intensive pharmacokinetic serum sampling.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Area Under the Curve From 0 to Infinity (AUC0-∞) for EVG

  AUC 0 to Infinity for Elvitegravir (ng\*h/mL)

  72 hours

• AUC0-∞ for COBI

  AUC 0 to Infinity for Cobicistat (ng\*h/mL)

  72 hours

• AUC0-∞ for FTC

  AUC 0 to Infinity for Emtricitabine (ng\*h/mL)

  72 hours

• AUC0-∞ for Tenofovir (TFV)

  AUC 0 to Infinity for TFV (ng\*h/mL)

  72 hours

Secondary Outcomes (7)

• EVG Cmax

  72 Hr

• FTC Cmax

  72 hr

• TFV Cmax

  72 hr

• EVG Half-life

  72 hours

• COBI Half-life

  72 hours

Study Arms (2)

Genvoya Oral dose

ACTIVE COMPARATOR

Single observed oral dose of Genvoya whole tablet

Drug: Genvoya Oral dose

Genvoya Crushed Dose

EXPERIMENTAL

Single observed oral dose of Genvoya crushed tablet

Drug: Genvoya Crushed Dose

Interventions

Genvoya Oral dose DRUG

Single Genvoya oral dose directly observed

Also known as: elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide

Genvoya Oral dose

Genvoya Crushed Dose DRUG

Single Genvoya crushed tablet in water directly observed

Also known as: elvitegravir/cobicistat/emtricitabine/ tenofovir alafenamide

Genvoya Crushed Dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female research participants, ≥18 years of age.
• Negative HIV-1/2 Ag/Ab serology documented within 30 days prior to study entry.
• Negative Hepatitis B surface antigen within 30 days prior to study entry.
• Ability and willingness of subject to provide a signed informed consent and comply with study requirements.
• Negative qualitative urine pregnancy test.
• All subjects must not participate purposely in a conception process (e.g., active attempt to impregnate, sperm donation, or in vitro fertilization). If participating in sexual activity that could lead to pregnancy subjects must take every precaution to avoid risk of pregnancy by using a reliable contraception for the duration of the study therapy (e.g., condoms, hormonal, barrier).
• Laboratory values and physical examination as judged by the principal investigator to be safe to participate including normal renal function.
• Good peripheral venous access for proposed pharmacokinetic sampling.
• Willingness and ability to take oral medications.

You may not qualify if:

• History of chronic or acute medical conditions that in the opinion of the investigator would jeopardize safety of subjects participating in this study.
• Known or suspected hypersensitivity to the components of Genvoya.
• Use of prescription or over-the-counter medications, including agents containing polyvalent cations (e.g., Mg, Al, Fe, or Ca), or any other drugs that in the opinion of the investigator could interfere with the pharmacokinetics of any of the ARV components of Genvoya within 2 weeks prior to either study dose.
• Pregnant or breast feeding.
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
• Hospitalization or therapy for serious illness within 30 days prior to study entry as judged by the investigator.
• Participation in any investigational drug study within 30 days prior to study entry that in the opinion of the investigator would preclude study participation.
• Taking any medication listed in the package insert that is contraindicated with Genvoya.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Andrade A, Fuchs EJ, Marzinke MA, Abdul Massih S, Breakey J, Beselman S, McNicholl I, Hendrix CW. EVG/COBI/FTC/TAF Bioequivalence Comparing Whole Tablets with Tablets Dissolved in Tap Water. AIDS Res Hum Retroviruses. 2023 Jan;39(1):38-43. doi: 10.1089/AID.2022.0085. Epub 2022 Dec 22.

  PMID: 36301928 DERIVED

MeSH Terms

Interventions

elvitegravir; tenofovir alafenamide

Results Point of Contact

• Title: Dr. Craig Hendrix
• Organization: Johns Hopkins University

chendrix@jhmi.edu

4109559707

Study Officials

• Craig Hendrix, MD

  JHU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2018
• First Posted: October 24, 2018
• Study Start: April 15, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: January 31, 2023
• Results First Posted: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)